Dengue vaccine is incorporated into the SUS – 12/21/2023 – Health

The Ministry of Health announced this Thursday (21) the incorporation of the dengue vaccine into the SUS. Vaccination should begin in February 2024, but will not be used on a large scale at first.

According to the ministry, the Takeda laboratory, manufacturer of the Qdenga vaccine, stated that it has a restricted capacity to supply doses. Therefore, vaccination will be aimed at the public and priority regions.

“The Ministry of Health assessed the cost-benefit ratio and the issue of access, since in a country like Brazil it is necessary to have an adequate quantity of vaccines for the size of our population. Based on Conitec’s favorable opinion, we will be the first country to give public access to this vaccine, as a SUS immunizer”, said the Minister of Health, Nísia Trindade.

According to her, by the beginning of the year, the ministry will define the target audience taking into account the Takeda company’s limitation on the number of vaccines available. Regions with a higher incidence of the disease will have priority.

These strategies should be defined in the first weeks of January. According to the laboratory, the forecast is that 5.082 million doses will be delivered in 2024, between February and November. The vaccination schedule consists of two doses.

Since the registration of the Qdenga (Takeda) vaccine was approved by Anvisa (National Health Surveillance Agency) in March 2023, posts on social media questioned the government of President Luiz Inácio Lula da Silva (PT) regarding the delay in incorporating the immunization to the SUS (Unified Health System).

Currently, it is only possible to get vaccinated in the private network, where the vaccine is offered at prices ranging from R$300 to R$800 per dose — the manufacturer recommends taking two.

Cases are on the rise and worry experts and health officials. This year alone (until December 2), the country had 1.6 million cases, 15.8% more than the same period last year, with an increase in deaths in the period — from 999 to 1,053. The city of São Paulo also recorded a 9% increase in deaths in 2023.

“The year 2023 was really different. We had these changes caused by the El Niño phenomenon. And, after a long time, we found the four serotypes (1, 2, 3 and 4) circulating at the same time in Brazil, a very unusual situation “, said the Secretary of Health and Environmental Surveillance, Ethel Maciel.

The Ministry of Health reported that it will invest R$256 million in strengthening arbovirus surveillance.

According to Carlos Gadelha, Secretary of Science, Technology and Innovation and the Health Economic-Industrial Complex, in the process of incorporating the dengue vaccine, the ministry achieved an 80% reduction in the price initially presented, representing a saving of more than R $380 million to SUS.

The public consultation was carried out urgently, for a period of ten days, and received more than 2,000 contributions. Still during negotiations with the manufacturer, the Ministry of Health achieved a 44% reduction in the cost per dose: going from the initial offer of R$170 to R$95.

“The next step is to stimulate the country’s productive capacity, encourage innovation and technology transfer processes to expand the supply of products to the population”, says Gadelha.

The immunizer reduces cases and, especially, hospitalization due to the disease. The strategy will be added to other forms of combating subtypes of the virus that circulate in Brazil, mainly with actions to control Aedes aegypti.

The Qdenga immunizer is registered with Anvisa with indication for preventing dengue fever caused by any serotype of the virus for people aged 4 to 60 years, regardless of previous exposure. It is made up of four different serotypes of the virus and must be applied in a two-dose schedule, with an interval of three months between applications.

In October, the WHO (World Health Organization) started to recommend the vaccine,

In addition to Qdenga, another vaccine against dengue is being produced in the country. The Butantan Institute, in partnership with the pharmaceutical company MSD (acronym in English for Merck Sharp and Dohme), is developing a single-dose vaccine, called Butantan-DV.

The vaccine is derived from a technology from the National Institutes of Health in the United States, licensed in 2009. Phases 1 and 2 of the clinical trial were developed in the USA (2010-2012) and in Brazil (2013-2015), respectively. The information is available on the Butantan Portal, in a publication dated December 16, 2022.

The first two phases of the clinical trial showed that the vaccine induces the production of antibodies against the four serotypes of the virus, which, according to the Butantan Institute, is the biggest challenge in producing an immunizer against dengue. The difficulty is explained by the fact that it is possible to be infected more than once by the different serotypes, with a chance of worsening the disease and risk of death.

Preliminary results from phase 3, which began in 2016, showed an effectiveness of 79.6% in preventing the disease. The data was obtained from monitoring more than 16 thousand Brazilians who received the vaccine for two years.

During the defined period, no trial participant presented a serious case of dengue. Volunteers aged 2 to 59 years old were evaluated. The study is expected to end in 2024, when the last participant completes five years of follow-up.